In 1911, a federal office with four employees charged with protecting consumer health—two chemists, an inspector and a clerk—opened in four rooms in the Federal Courthouse Building in San Juan, Puerto Rico.

It was just five years after the passage of the 1906 Pure Food and Drugs Act—the first federal food and drug statute enacted to protect consumers from illegal foods and drugs moving in interstate commerce.

Today, the San Juan District Office, including a drug specialty laboratory, is situated on four acres of FDA-owned land facing the city's harbor. It is still charged with protecting consumer health, but the number of products that the office oversees has multiplied; its capabilities and the size of its staff have expanded; and its duties are now global.

"They have a passion for what they do and take their mission of protecting consumers and enhancing public health very seriously," says District Director Maridalia Torres. "We are the smallest district but we have a big heart."

Alliances Important

Separated by a thousand miles of ocean from the continental U.S., the San Juan District Office serves the Commonwealth of Puerto Rico and the Territory of the U.S. Virgin Islands. District employees are responsible for ensuring that FDA-regulated products made or sold in these territories—or imported into them—comply with FDA regulations.

These efforts include investigations, enforcement and laboratory analysis. In addition, the district promotes public health through education, health communications and the media through alliances with local municipalities, advocacy groups and others.

In the international arena, San Juan District staff members help train representatives of regulatory agencies throughout Latin America and the Caribbean, and inspect facilities in foreign countries, such as China, India and European nations.

Historical Journey

In the early years of the San Juan office—named the San Juan Section in 1965—much of Puerto Rico's food supply came from the mainland U.S. and foreign countries. "A substantial part of the San Juan Section's inspectional and laboratory manpower is devoted to imported food products," according to the writings of Harry P. Lynch, a former San Juan section chief who joined FDA in 1955.

Today, the San Juan District, as it was renamed in 1971, still devotes many of its staff to monitoring a variety of commodities—including food products—that arrive into the U.S. through 15 ports in Puerto Rico and the U.S. Virgin Islands.

During its journey, the district has seen Puerto Rico make the transition from a primarily agricultural region to a diverse industrial sector. Although the food industry represents half of the 1,500 facilities that the district inspects, the other half includes drug and medical device manufacturing facilities, blood banks and other biological facilities, biotechnology, and animal drug and feed facilities.

In 1960, there was only one U.S. drug company with a manufacturing plant in Puerto Rico, according to Lynch. Today, the government-owned Puerto Rico Industrial Development Company (PRIDCO) reports that Puerto Rico is home to 79 FDA-regulated pharmaceutical plants and 59 medical device manufacturing plants.

"Our district is the smallest of FDA's 20 districts, yet we are known for regulating the largest concentration of worldwide high-profile pharmaceutical and medical device manufacturers," says Torres. Ninety percent of the world's pacemakers are manufactured in Puerto Rico, according to PRIDCO.

In 2011, the district celebrated the 100th anniversary of FDA presence in Puerto Rico.

Specialty Laboratory

In its early years, the San Juan Station's laboratory examined drug and food samples for "shortage of contents, ingredients, and false and misleading labels," according to the writings of Mario Brau Jr., who joined the station as a clerk in 1921.

"Most of the work of the station was done for the U.S. Customs Service, the U.S. Department of Agriculture, and the Prohibition Department," writes Brau. "For U.S. Customs, we examined and analyzed many imported goods."

Today the San Juan Laboratory specializes in drug analysis. Whether responding to a consumer complaint or supporting a criminal investigation, the lab is equipped and analysts are prepared to examine all forms of drugs—whether tablets, capsules, creams, sprays, suspensions, ophthalmic solutions, inhalers, or transdermal patches.

"FDA is the oldest consumer protection agency in the world and San Juan District employees have been there, helping to lead and shape the agency, from the beginning," says Melinda Plaisier, FDA's associate commissioner for regulatory affairs. "The rich history that the San Juan district brings to FDA—the legacy of those who have served and those who serve today—is an invaluable part of both the fabric of the FDA family and public health protection."